Phakic Toric Intraocular Lens
Ophthalmic · 21 CFR 886.3600
Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.
Recent MDR events
18,233 adverse event reports on file
- EVO/EVO+ VISIAN Implantable Collamer Lens (ICL)Jul 31, 2026InjuryStaar Surgical Company2023826-2026-01425
- EVO/EVO+ VISIAN Implantable Collamer LensJul 31, 2026InjuryStaar Surgical Company2023826-2026-01427
- EVO/EVO+ VISIAN Implantable Collamer LensJul 31, 2026InjuryStaar Surgical Company2023826-2026-01426
- EVO/EVO+VISIAN Implantable Collamer LensJul 29, 2026InjuryStaar Surgical Company2023826-2026-01347
- EVO/EVO+VISIAN Implantable Collamer LensJul 29, 2026InjuryStaar Surgical Company2023826-2026-01342
- EVO/EVO+VISIAN Implantable Collamer LensJul 29, 2026InjuryStaar Surgical Company2023826-2026-01343
- EVO/EVO+VISIAN Implantable Collamer LensJul 29, 2026InjuryStaar Surgical Company2023826-2026-01359
- EVO/EVO+VISIAN Implantable Collamer LensJul 29, 2026InjuryStaar Surgical Company2023826-2026-01341
- EVO/EVO+ VISIAN Implantable Collamer Lens (ICL)Jul 29, 2026InjuryStaar Surgical Company2023826-2026-01396
- EVO/EVO + VISIAN Implantable Collamer Lens (ICL)Jul 29, 2026InjuryStaar Surgical Company2023826-2026-01401
Event type breakdown
Recalls
5 recall events for this product code
- Staar Surgical AGOpen, ClassifiedMar 2, 2026
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
Z-1480-2026 · View FDA record ↗ - Staar Surgical CompanyOpen, ClassifiedDec 1, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
Z-0470-2024 · View FDA record ↗ - Staar Surgical CompanyOpen, ClassifiedDec 1, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
Z-0471-2024 · View FDA record ↗ - Staar Surgical CompanyOpen, ClassifiedDec 1, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
Z-0472-2024 · View FDA record ↗ - Staar Surgical CompanyOpen, ClassifiedDec 1, 2023
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
Z-0473-2024 · View FDA record ↗
Registered firms
3 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.